Federal Register notice: FDA makes available a final guidance entitled Instructions for UsePatient Labeling for Human Prescription Drug and Biological...
FDA approves a Provepharm NDA for Bludigo (indigotindisulfonate sodium), a diagnostic dye indicated for use as a visualization aid in the cystoscopic ...
The House Energy and Commerce Committee leadership calls on the Senate to urgently reauthorize FDAs user fee programs.
Hospira recalls one lot of propofol injectable emulsion due to the presence of a visible particulate in a single retained vial from the lot.
FDA solicits comments on software functions excluded from the medical device definition by the 21st Century Cures Act.
FDA publishes a guidance on the content and format of patient instructions for use documents for prescription drugs and biologics.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Genentechs Enspryng (satralizumab-mwge).
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Blenrep (belantamab mafodotin-...